Fingolimod real life experience in non-naive multiple sclerosis patients
Abstract
Objectives: Fingolimod is approved in Turkey or the treatment of cases of multiple sclerosis (MS) which cannot be controlled with first-line treatments. There is limited information about its efficacy and safety in clinical practice in Turkey. The aim of this study was to evaluate the efficacy and safety of fingolimod treatment in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by the Multiple Sclerosis specialists of Bursa Uludağ University Department of Neurology.
Methods: This is a single-center observational study evaluating 142 patients using fingolimod who were followed up for at least 12 months in our center between April 2015 and October 2022. Efficacy results were evaluated in terms of mean number of attacks, annualized relapse rate, relapse-free patient rate, disease progression, clinical and radiological disease activity, and no evidence of disease activity (NEDA-3). The safety outcomes are the rates of treatment-related severe adverse events and patients' continuation rates.
Results: Over 12 months of treatment with fingolimod, the average number of attacks decreased by 94.6%, the annual relapse rate decreased by 87%, and most patients did not relapse (83.1%). Alongside this, in 76.4% of cases, there was no disability progression and in 83.3% of cases, magnetic resonance imaging (MRI) activation was not observed. Excluding replacement due to ineffectiveness, 89.4% of patients continued fingolimod therapy. Cardiac events, treatment-related infections and a decreased lymphocyte count were observed as side effects.
Conclusion: In our center, switching from first-line treatments to fingolimod was effective in reducing disease activity in patients with multiple sclerosis.
Keywords
References
- 1. Compston A, Coles A. Multiple sclerosis. Lancet. 2008;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
- 2. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998;352(9139):1498-504.
- 3. Cohen JA, Barkhof F, Comi G, et al; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):402-15. doi: 10.1056/NEJMoa0907839.
- 4. Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387-401. doi: 10.1056/NEJMoa0909494.
- 5. Calabresi PA, Radue EW, Goodin D, et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3.
- 6. Mazibrada G, Sharples C, Perfect I. Real-world experience of fingolimod in patients with multiple sclerosis (MS Fine): An observational study in the UK. Mult Scler J Exp Transl Clin. 2018;4(4):2055217318801638. doi: 10.1177/2055217318801638.
- 7. Walczak A, Kurkowska-Jastrzebska I, Zakrzewska-Pniewska B, et al. Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis. Clin Neurol Neurosurg. 2019;184:105453. doi: 10.1016/j.clineuro.2019.105453.
- 8. Ziemssen T, Lang M, Tackenberg B, et al; PANGAEA study group. Real-world persistence and benefit-risk profile of fingolimod over 36 months in Germany. Neurol Neuroimmunol Neuroinflamm. 2019;6(3):e548. doi: 10.1212/NXI.0000000000000548.
Details
Primary Language
English
Subjects
Neurology and Neuromuscular Diseases
Journal Section
Research Article
Authors
Furkan Sarıdaş
*
0000-0001-5945-2317
Türkiye
Emine Rabia Koç
0000-0002-0264-7284
Türkiye
Güven Özkaya
0000-0003-0297-846X
Türkiye
Ömer Faruk Turan
0000-0002-6752-1519
Türkiye
Early Pub Date
May 14, 2024
Publication Date
September 4, 2024
Submission Date
January 22, 2024
Acceptance Date
April 29, 2024
Published in Issue
Year 2024 Volume: 10 Number: 5